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CompletedNCT03679741Updated Dec 26, 2019Results posted

Initial Evaluation of Investigational Lenses Manufactured on a New Production Line

An interventional study of CONTROL Lens and TEST Lens in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-26.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. The subject must read and sign the Informed Consent form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
  4. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D.
  5. The subject's refractive cylinder must be ≤ 1.00 D in each eye.
  6. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  7. Subjects must own a wearable pair of spectacles.
  8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
  9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
  10. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
  3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
  4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).
  6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  7. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
  8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
  9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  10. Toric, extended wear, monovision or multi-focal contact lens correction.
  11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  12. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
  13. History of binocular vision abnormality or strabismus.
  14. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    TEST/CONTROL/CONTROL

    Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks.

    Device: CONTROL Lens · Device: TEST Lens

  • Experimental
    CONTROL/TEST/TEST

    Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks.

    Device: CONTROL Lens · Device: TEST Lens

Interventions

  • DeviceCONTROL Lens

    Acuvue OASYS

  • DeviceTEST Lens

    senofilcon A

06

What researchers measure

Primary outcomes

  1. Overall Comfort Score

    Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Time frame: 2-Week Follow-up

  2. Vision Satisfaction in Bright Lighting

    Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.

    Time frame: 2-Week Follow-up

  3. Distance Monocular LogMAR Visual Acuity

    Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.

    Time frame: 2-Week Follow-up

  4. Contact Lens Fitting Acceptance Rate

    Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.

    Time frame: Up to 2-Week Follow-up

  5. Number of Grade 3 or Higher Slit Lamp Findings

    Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.

    Time frame: Up to 2-Week Follow-up

Secondary outcomes

  1. Overall Quality of Vision Score

    Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Time frame: 2-Week Follow-up

  2. Overall Handling Scores

    Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Time frame: 2-Week Follow-up

  3. Overall Quality of Vision Indoors

    Overall Quality of Vision Indoors was assessed using the individual item" Overall Quality of Vision Indoors" from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type.

    Time frame: 2-Week Follow-up

07

Results

Posted Dec 26, 2019

Participant flow

A total of 126 subjects were enrolled into this study. Of those enrolled, 120 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 110 completed the study, while 10 subjects were discontinued.

Period 1
Participant flow — Period 1
MilestoneTest/Control/ControlControl/Test/Test
Started5961
Completed5758
Not completed23
Withdrew: No longer meet eligibility criteria10
Withdrew: Lost to follow-up01
Withdrew: Adverse event11
Withdrew: Withdrawal by subject01
Period 2
Participant flow — Period 2
MilestoneTest/Control/ControlControl/Test/Test
Started5758
Completed5456
Not completed32
Withdrew: Adverse event21
Withdrew: Withdrawal by subject11
Period 3
Participant flow — Period 3
MilestoneTest/Control/ControlControl/Test/Test
Started5456
Completed5456
Not completed00

Outcome measures

PrimaryOverall Comfort Score

Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame:
2-Week Follow-up
Reported as:
Mean · Units on a Scale
Overall Comfort Score
Units on a ScaleTestControl
Overall Comfort Score59.30 ± 23.77958.54 ± 22.303
Statistical analysis
  • Test vs Control · Bayesian multivariate normal random-effe · Mean difference (final values): 1.9 · 95% CI -1.9 to 5.8Mean difference was calculated as test minus control
PrimaryVision Satisfaction in Bright Lighting

Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.

Time frame:
2-Week Follow-up
Reported as:
Number · Proportion of participants
Vision Satisfaction in Bright Lighting
Proportion of participantsTestControl
Strongly Agree0.220.11
Agree0.6220.583
Neither Agree Nor Agree0.0980.141
Disagree0.0610.135
Strongly Disagree0.000.031
Statistical analysis
  • Test vs Control · Bayesian multinomial random-effects mode · Odds ratio (or): 3.97 · 95% CI 2.27 to 6.62Odds ratio was calculated as test over control
PrimaryDistance Monocular LogMAR Visual Acuity

Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.

Time frame:
2-Week Follow-up
Reported as:
Mean · logMAR
Distance Monocular LogMAR Visual Acuity
logMARTestControl
High Illumination low contrast0.10 ± 0.0860.14 ± 0.089
Low illumination high contrast0.06 ± 0.0820.08 ± 0.085
Statistical analysis
  • Test vs Control · Bayesian multivariate normal model · Mean difference (final values): -0.022 · 95% CI -0.037 to -0.008Mean difference was calculated as Test minus Control
  • Test vs Control · Bayesian multivariate normal model · Mean difference (final values): -0.034 · 95% CI -0.049 to -0.020Mean difference was calculated as Test minus Control
PrimaryContact Lens Fitting Acceptance Rate

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.

Time frame:
Up to 2-Week Follow-up
Reported as:
Number · percentage of eyes
Contact Lens Fitting Acceptance Rate
percentage of eyesTestControl
Contact Lens Fitting Acceptance Rate100100
Statistical analysis
  • Test · Bayesian beta- binomial model · Mean percentage of eyes: 100.0 · 95% CI 99.0 to 100.0for correlated binary data
PrimaryNumber of Grade 3 or Higher Slit Lamp Findings

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.

Time frame:
Up to 2-Week Follow-up
Reported as:
Number · proportion of eyes
Number of Grade 3 or Higher Slit Lamp Findings
proportion of eyesTestControl
Number of Grade 3 or Higher Slit Lamp Findings0.0050.000
Statistical analysis
  • Test vs Control · Bayesian beta-binomial hierarchical · Mean difference (final values): 0.001 · 95% CI -0.004 to 0.008Mean difference was calculated as Test minus Control.
SecondaryOverall Quality of Vision Score

Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame:
2-Week Follow-up
Reported as:
Mean · Units on a Scale
Overall Quality of Vision Score
Units on a ScaleTestControl
Overall Quality of Vision Score62.25 ± 18.46058.47 ± 18.707
Statistical analysis
  • Test vs Control · Bayesian multivariate normal model · Mean difference (final values): 5.6 · 95% CI 3.1 to 8.1Mean difference was calculated as test minus control
SecondaryOverall Handling Scores

Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame:
2-Week Follow-up
Reported as:
Mean · Units on a Scale
Overall Handling Scores
Units on a ScaleTestControl
Overall Handling Scores66.24 ± 19.18564.66 ± 20.460
Statistical analysis
  • Test vs Control · Bayesian multivariate normal model · Mean difference (final values): 2.5 · 95% CI -0.6 to 5.5Mean difference was calculated as test minus control
SecondaryOverall Quality of Vision Indoors

Overall Quality of Vision Indoors was assessed using the individual item" Overall Quality of Vision Indoors" from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type.

Time frame:
2-Week Follow-up
Reported as:
Number · Proportion of participants
Overall Quality of Vision Indoors
Proportion of participantsTestControl
Excellent0.4330.374
Very Good0.3960.393
Good0.1280.184
Fair0.0430.049
Poor00
Not Applicable00
Statistical analysis
  • Test vs Control · Bayesian multinomial random-effects · Odds ratio (or): 1.73 · 95% CI 1.00 to 2.82Odds ratio was calculated as test over control

Adverse events

Collected over Throughout the entire duration of the study. Approximately 6-Weeks per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test0/120 (0%)0/120 (0%)0/120 (0%)
Control0/120 (0%)0/120 (0%)0/120 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Dispensed Subjects
Mean33.3 ± 8.02
Sex: Female, Male
Sex: Female, Male(Participants)All Dispensed Subjects
Female91
Male29
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)All Dispensed Subjects
Asian11
Black or African American7
White102
Region of Enrollment
Region of Enrollment(Participants)All Dispensed Subjects
United States120
08

Study locations

6 sites
  • Randall Go, OD
    San Francisco, California 94110, United States
  • VRC-East
    Jacksonville, Florida 32256, United States
  • Sacco Eye Group
    Vestal, New York 13850, United States
  • Pickens Eye Care
    Pickens, South Carolina 29671, United States
  • William J. Bogus, OD, FAAO
    Salt Lake City, Utah 29671, United States
  • Botetourt Eyecare, LLC
    Roanoke, Virginia 24153, United States
09

References and documents

Study documents

  • Statistical analysis plan · Nov 14, 2018
  • Study protocol · Aug 9, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03679741
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Sep 20, 2018
Start date
Aug 29, 2018
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Results posted
Dec 26, 2019
Last update
Dec 26, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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